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Trial Title:
177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study
NCT ID:
NCT05496959
Condition:
Oligometastatic Prostate Carcinoma
Prostate Adenocarcinoma
Recurrent Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lutetium Lu-177 PNT2002
Description:
Given IV
Arm group label:
Arm 2 (177Lu-PNT2002, SBRT)
Other name:
177Lu-labeled PNT2002
Other name:
177Lu-PNT2002
Other name:
[Lu-177]-PNT2002
Other name:
[Lu-177]-PSMA-I and T
Other name:
Lu177-PNT2002
Other name:
Lutetium Lu-177-PNT2002
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Arm 1 (SBRT)
Arm group label:
Arm 2 (177Lu-PNT2002, SBRT)
Other name:
Quality of Life Assessment
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo SBRT
Arm group label:
Arm 1 (SBRT)
Arm group label:
Arm 2 (177Lu-PNT2002, SBRT)
Other name:
SABR
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
Summary:
This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body
radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate
cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive
drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not
harm normal cells. SBRT uses special equipment to position a patient and deliver
radiation to tumors with high precision. This method may kill tumor cells with fewer
doses over a shorter period and cause less damage to normal tissue. Giving
177-Lutetium-PSMA before SBRT may make the SBRT more effective.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess progression-free survival for men with oligorecurrent prostate cancer after
stereotactic body radiotherapy (SBRT) versus SBRT plus neoadjuvant lutetium Lu-177
PNT2002 (177Lu-PNT2002), with progression defined on the basis of prostate-specific
membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT) scans
obtained at standard intervals (12 months and 24 months post-SBRT) or at the time of
prostate-specific antigen (PSA)-based biochemical progression, or initiation of salvage
therapy or death.
SECONDARY OBJECTIVES:
I. To evaluate disease burden of disease (including local control of irradiated lesions
and presence of other disease) on a PSMA PET/CT obtained 24 months after SBRT of SBRT
versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease who have not
progressed by that point.
II. To assess physician-scored toxicity (Common Terminology Criteria for Adverse Events
version 5.0 [CTCAE v 5.0]) of SBRT versus SBRT + 177Lu-PNT2002 in patients with
oligometastatic disease.
III. To assess patient-reported quality of life (based on the brief pain inventory scale)
after SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.
IV. To assess androgen deprivation therapy (ADT)-free survival after SBRT versus SBRT +
177Lu-PNT2002 in patients with oligometastatic disease.
V. To determine local control of irradiated lesion at 12 months after SBRT versus SBRT +
177Lu-PNT2002 in patients with oligometastatic disease (based on a scheduled PSMA-PET).
VI. To assess time to locoregional progression, time to distant progression, time to new
metastasis, and duration of response after SBRT versus SBRT + 177Lu-PNT2002 in patients
with oligometastatic disease (based on standard of care imaging).
CORRELATIVE OBJECTIVES:
I. To enumerate circulating tumor cells (CTCs) and circulating tumor deoxyribonucleic
acid (ctDNA) at baseline, 3 months, 6 months, and 12 months after SBRT.
II. To quantitatively sequence T-cell receptor (TCR) repertoires using peripheral blood
monocytes at baseline, 3 months, 6 months, and 12 months after SBRT.
III. To perform radiomics analysis on PSMA PET/CT scans performed at +12 months (mo.),
+24 months post-SBRT, or at time of progression.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Beginning on day 1, patients undergo SBRT to all lesions for 1, 3, or 5 treatment
doses (fractions) over the span of 10-20 days in the absence of disease progression or
unacceptable toxicity.
ARM 2: Patients receive 177Lu-PNT2002 intravenously (IV) over 1-10 minutes on days -112
and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day
1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions)
over the span of 10-20 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment patients are followed up at 1, 3, 6, 9, and 12
months, then every 6 months until 60 months of total follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic
lesions outside the prostate or prostate bed identified on PSMA PET/CT by local
readers
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- No indication for urgent or emergent radiation
- Histologic confirmation of prostate adenocarcinoma (histology from original
treatment acceptable)
- White blood cell count >= 2.5 × 10^9/L
- Platelets >= 100 × 10^9/L
- Hemoglobin >= 9 g/dL
- Total bilirubin =< 1.5 × institutional upper limit of normal (ULN); or up to 3 × ULN
if known history of Gilbert's syndrome
- Alanine aminotransferase or aspartate aminotransferase =< 3.0 × ULN or =< 5.0 × ULN
for patients with liver metastases
- Serum creatinine =< 1.5 × ULN or creatinine clearance >= 50 mL/min
- Serum albumin > 3.0 g/dL
- Partner and patient must use a method of birth control with adequate barrier
protection, deemed acceptable by the principal investigator during the study and for
3 months after last study drug administration
- Ability to understand, and willingness to sign, the written informed consent
Exclusion Criteria:
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Patients with castrate-resistant disease (i.e., PSA > 0.5 ng/mL with serum
testosterone < 150 ng/dL)
- Patients who received androgen deprivation therapy within 6 months of trial
enrollment
- Concurrent systemic therapy for a solid organ malignancy
- Spinal cord compression
- Inability to lie flat
- Known hypersensitivity to components of 177Lu-PNT2002
- Serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min
- Total bilirubin > 1.5 × ULN or > 3.0 × ULN if known history of Gilbert's syndrome
- Alanine aminotransferase or aspartate aminotransferase > 3 × ULN (or 5 × ULN for
patients with known liver metastases)
- De novo oligometastatic disease
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCLA / Jonsson Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Start date:
September 2, 2022
Completion date:
September 1, 2033
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Agency class:
Industry
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05496959